Promoting Healthy Development With the Recipe 4 Success Intervention

June 4, 2019 updated by: University of Wisconsin, Madison

Promoting Healthy Development With the Recipe 4 Success Intervention: A Randomized Controlled Trial

10-session home visit intervention conducted within Early Head Start and designed to reduce low-income toddler's obesity risk and improve their self-regulation skills and parents' sensitivity.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Recipe 4 Success, the product of a university-community engagement collaboration, uses 10 tightly sequenced, structured, and scripted food preparation lessons, delivered as part of Early Head Start home visits, to help low-income parents learn to sensitively scaffold their toddler's self-regulation skills and establish more healthy eating habits. The intervention relies on an active coaching therapeutic approach to deliver content. Recipe 4 Success is focused on parents because their feeding practices influence children's diet, and interventions to prevent childhood obesity are most likely to have long-term effects when they emphasize positive parenting practices. Parents' sensitivity and constructive scaffolding behaviors are related to children's self-regulation skills, which are robust predictors of healthy eating habits and body mass index (BMI). For example, children who have difficulty with self-regulation by age 3 have a higher BMI through age 12. Importantly, these relations may be causal: Adults who are taught self-regulation skills appear more successful in maintaining healthy eating habits over time. As a preventive intervention, Recipe 4 Success is implemented when children are 2, the point at which deliberate self-regulation skills are starting to emerge and develop rapidly and taste preferences are being formed. Recipe 4 Success is designed for families living in poverty because parents are less likely to provide sensitive scaffolding and children are less likely to display well-developed self-regulation skills and healthy eating habits under conditions of economic adversity. Finally, Recipe 4 Success was created to be integrated into Early Head Start to expedite wide-spread dissemination and easy sustainability and to enhance the efficacy of this nation-wide home visit program. If successful, this will be one of the first preventive interventions to improve either toddler's self-regulation skills or their healthy eating habits and BMI.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
73

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 year to 3 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Family lives in York, Allentown, Williamsport/Lock Haven Pennsylvania
  • Family enrolled in Early Head Start home visit program
  • Target child 18-36 months old at beginning of study

Exclusion Criteria:

  • Family considered "in crisis" by home visitor (i.e., not able to focus on new intervention lessons because of child custody, family violence, mental health, or housing issues that currently demand parents' full attention)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Recipe 4 Success intervention
10 lessons delivered across 10 successive weeks within Early Head Start infrastructure by families' regular Early Head Start home visitors. Lessons involved active coaching in which parents and children prepared healthy snacks or meals. Lessons also included information on children's self-regulation skills and healthy eating habits.
Behavioral: Recipe 4 Success

The Recipe 4 Success intervention consisted of 10 weekly lessons in which parents and toddlers prepared simple snacks or meals.

All Recipe 4 Success lessons started and ended with some evidence-based information for the parents about children's self-regulation skills or healthy eating habits. Most of each lesson in Recipe 4 Success was devoted to the snack or meal preparation activities. Each week, home visitors coached the parents as they worked with their toddlers to make increasingly challenging snacks and meals. During these activities, home visitors pointed out opportunities for parents to practice sensitive scaffolding strategies. At the same time, these meal and snack preparation activities allowed children to practice multiple age-appropriate self-regulation skills.
Active Comparator: Treatment as usual Early Head Start
Regular Early Head Start home visitors continued to implement evidence-informed developmentally appropriate curriculum designed to promote children's physical health, cognitive skills, and social-emotional functioning as well as parents' capacities to support their children's development.
Behavioral: Treatment as Usual Early Head Start
Treatment as Usual Early Head Start consisted of an evidence-based curriculum (usually Parents as Teachers) in which home visitors and parents worked with children on activities to support their physical, cognitive, and social-emotional development.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in percentage of healthy meals consumed
Time Frame: Change across three months, from baseline to post-intervention
Daily food diaries were collected across three 24-hour periods. The percentage of meals that included at least one fruit and/or vegetable, at least one source of protein, and that did not include any sweets or junk food was calculated.
Change across three months, from baseline to post-intervention
Change in willingness to eat healthy food
Time Frame: Change across three months, from baseline to post-intervention
As part of the study assessment battery, parents were given novel healthy foods, such as dried seaweed, and asked to see if their children would like to eat them. The percentage of novel foods that children at least tasted was calculated.
Change across three months, from baseline to post-intervention
Change in healthy body weight
Time Frame: Change across three months, from baseline to post-intervention
Children's weight and height were collected with standardized scales and tape measures.
Change across three months, from baseline to post-intervention
Change in children's self-control skills
Time Frame: Change across three months, from baseline to post-intervention
Children completed a snack delay task in which an M&M was placed on a plate but the interviewer asked the children to wait 5-60 seconds before eating the M&M. The percentage of the four trials in which the child was able to wait the entire time requested before eating the M&M was calculated.
Change across three months, from baseline to post-intervention
Change in children's attention
Time Frame: Change across three months, from baseline to post-intervention
Children and their parents participated in three interaction tasks. Raters blind to study condition rated the ability of the children to concentrate and stay focused on what they were doing with their parents on a Likert scale with 1=almost never to 5 = almost always.
Change across three months, from baseline to post-intervention
Change in children's compliance
Time Frame: Change across three months, from baseline to post-intervention
Parents' completed the 8-item compliance subscale of the well-validated Infant and Toddler Social and Emotional Assessment. Each item was rated on a Likert scale with 1 = not true to 3 = very true.
Change across three months, from baseline to post-intervention
Change in parents' sensitive scaffolding
Time Frame: Change across three months, from baseline to post-intervention
Children and their parents participated in three interaction tasks. Raters blind to study condition rated the ability of the parents to sensitively scaffold their children's learning of a new task on a Likert scale with 1=almost never to 5 = almost always.
Change across three months, from baseline to post-intervention
Change in parents' competent parenting
Time Frame: Change across three months, from baseline to post-intervention
Children and their parents participated in three interaction tasks. Raters blind to study condition rated the overall competence of the parents on four items such as "The parent seemed very effective in interacting with the child" on a Likert scale with 1=almost never to 5 = almost always.
Change across three months, from baseline to post-intervention
Change in parents' supportive feeding behaviors
Time Frame: Change across three months, from baseline to post-intervention
As part of the study assessment battery, parents were given novel healthy foods, such as dried seaweed, and asked to see if their children would like to eat them. Interviewers blind to study condition rated whether or not parents engaged in four behaviors for each specific snack, such as "Parent modeled enjoyment of health food by tasting it her/himself." The percentage of times parents demonstrated such supportive feeding behaviors was calculated.
Change across three months, from baseline to post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Wisconsin, Madison

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Penn State University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Robert Nix, Ph.D., University of Wisconsin-Madison (previously Pennsylvania State Univeristy)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 5, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 27, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 27, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 3, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 5, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 5, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Recipe4Success

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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